Principal Statistical Programmer FSP - Oncology

Sponsor-dedicated:
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership.

This is an exciting time to be a part of this new program.

Position Overview:

This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel.  The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner.

This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials.

Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty years, Cytel’s scientific rigor and operational excellence have helped biotech and pharmaceutical companies navigate uncertainty, prove value and unlock the full potential of their data.

Come be a part of a team where talent, experience and scientific rigor come together to advance the state of clinical development. As the industry's largest provider of statistical software and advanced analytics, Cytel is home to some of the most innovative, collaborative and rigorous biostatistics, statistical programming and data management talent. Cytel careers offer meaningful work and stimulating challenges within a welcoming and diverse global culture.

Whether your specialty is biostatistics, statistical programming, adaptive clinical trial design, clinical data management, Bayesian statistics, real-world evidence, artificial intelligence, health economics, or a corporate function, you will be growing an exciting career while contributing to advancing the future of human health rch our open jobs or get in touch today to find your fit!
Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:

At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies

Experience in oncology endpoints and analyses

Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment

Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation

Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities

Must be able to work independently

Outstanding communication skills (written and verbal) and strong leadership skills

Preferred Qualifications (nice to have)
Proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)
As a Principal Statistical Programmer, your responsibilities will include:
Generate SDTM, ADaM specifications,…